Following is a P and T Committee update (from the March 26^th meeting).  Starting dates for specific programs listed below is April 1^st, 2013, unless otherwise noted.  This information should be available soon in the formulary notebooks, the formulary website, and Formulary One-Source.  Please let me know if you have any questions or comments.  Don’t forget to check the “New Drug Monitoring” of the website, which provides important monitoring information about newly approved drugs.  Also, attached is the updated version of the “Not Stocked, Not Ordered” drug list with the new additions highlighted in red. 

Below is the memo with links to the drug monographs, protocols, and formulary documents. Click to access the full P&T packet for this month, or here to access the P&T packet archive.

ingenol mebutate (Picato Gel) - This topical product is used for actinic keratosis, and for face/scalp the 0.015% is applied for 3 days, for the trunk/extremity the 0.05% is applied for 2 days.  The drug costs almost $600 per 2 -3 day treatment period.  It was classified as non-formulary, not stocked, and initiation should be deferred to outpatient therapy.  The inpatient may use their own supply if necessary.

budesonide (Uceris) extended release– This once daily tablet is indicated for induction of remission in patients with active, mild to moderate ulcerative colitis.  The dose is 9 mg once daily for up to 8 weeks.  The budesonide is released in a time dependent manner once exposure to pH greater than 7 occurs (i.e. in small intestine), and targets drug exposure to the entire colon.  The cost is nearly $40 daily.  The drug was classified as formulary, restricted to use for inpatients who are admitted already on the drug and cannot use their own home supply.  Initiation should be deferred to the outpatient setting.  If inpatient drug management is needed, other formulary agents such as predniSONE, mesalamine preparations, and others should be used until discharge.

amoxicillin/clarithromycin/omeprazole (Omeclamox) - This product is available as a triple-drug pack, including omeprazole, clarithromycin, and amoxicillin, and is used to treat H. Pylori infection associated with an active duodenal ulcer or with a history of duodenal ulcer disease.  The dose is omeprazole 20 mg, clarithromycin 500 mg, and amoxicillin 1000 mg bid for 10 days, and with an active ulcer the PPI should be continued for another 3 weeks.  This drug pack costs about $400, but giving the drugs separately costs about $40.  Omeclamox was classified as non-formulary, not stocked, and the drugs should be dispensed separately.  For omeprazole 20 mg bid, pantoprazole 40 mg once daily should be used. 

Prepopik - This is a colonoscopy bowel prep consisting of sodium picosulfate (a stimulant laxative),  magnesium oxide, and citric acid, supplied as a powder.  When reconstituted before use, the MgO and citric acid interact to form magnesium citrate.  Patients can take 2 doses the night before procedure, or take one dose the evening before and the morning of the procedure.  Efficacy appears similar to that of the PEG prep.  Prepopik costs $72/dose, versus $10 for PEG.  Prepopik was classified as non-formulary, not stocked, and our standard PEG formulary agent will be used instead.

lomitapide (Juxtapid) – This drug is approved for treatment of homozygous familial hypercholesterolemia (HoFH), which is a rare disorder.  It is used as adjunctive treatment and dosed from 5 mg up to 60 mg daily.  There is a strict REMS program requiring physician and pharmacy certification, patient registration and education, and monitoring.  The drug is classified as pregnancy category X and has a black box warning on hepatotoxicity.  The cost is over $800 / day, and is distributed only through a specialty pharmacy, and the hospital cannot order the drug specifically.  It was classified as non-formulary, not stocked, the inpatient should use their own supply if needed, and therapy initiation should be started in the outpatient setting.

methylphenidate (Quillivant XR) - This new drug is methylphenidate extended release liquid dosed once daily. It is available in several different amounts/volumes, and the cost of each unit of use is $167.  There is a 4 month expiration after reconstitution.  It was classified as non-formulary, not stocked, and another methylphenidate formulary agent should be used instead.  The patient may use their own supply of Quillivant XR. 

Milk / Molasses Enema – This preparation is a 1:1 mixture of  homogenized milk and molasses and used to treat constipation and fecal impaction, and is low cost.  There is utility particularly in the Pediatric Emergency Department setting.  This was approved for formulary use in the pediatric population.  Education will be done prior to stocking components in ER.

acetaminophen-HYDROcodone (Norco, Zamicet) combination liquids– As of January 2014, the FDA will limit the amount of acetaminophen in prescription combination products to 325 mg per dosage unit.  There is already a formulary program in place to convert hydrocodone / acetaminophen tablet products that contain over 325 mg of acetaminophen to a product containing 325 mg  (i.e. Norco, Percocet).  This was approved for the liquid products also;  a product containing hydrocodone and acetaminophen 325 mg /15 ml will be the standard formulary liquid combination product.

PHENobarbital (Luminal) Tablet Dose Standardization – PHENobarbital tablets were originally dosed in terms of grains and current products have converted the doses from grains to mg.  Depending on conversion factors used, there is some small variation in mg strength of different PHENobarbital tablets.  To reduce confusion, the following interchanges were approved:  15 mg interchanged to 16.2 mg, 30 mg to 32.4 mg, 60 mg to 64.8 mg, and 100 mg to 97.2 mg. 

Meperidine PCA Update – In January, due to a meperidine PCA national drug shortage and safety issues with the drug, meperidine PCAs were classified as non-formulary, not stocked.  This policy was updated to allow for restricted use with a pharmacy prepared syringe in patients with documented allergies to alternative agents, including morphine and DILAUDID for non-ICU patients and morphine, DILAUDID, and fentaNYL for ICU patients.  Meperidine PCA remains unavailable nationally so this product will be prepared in the Pharmacy.

UPI Product Update – The outsourced products potassium phosphate inj and furosemide inj. obtained from UPI were approved.  Both remain on back-order.  

ADE Report –  There were 108 ADEs reported in January and February, with 7 being judged preventable.  The drugs most frequently involved in the ADE reports were levofloxacin, vancomycin, and morphine, which are all highly used agents.  Insulin, Zosyn, and hydromorphone were involved with the 7 preventable reactions.  Causes of preventable reactions were excessive dosing and missing a documented allergy/ADR.

Look-alike / Sound-alike Drug Names – ZyrTEC – ZANTAC  was added to the list for Women and Children’s Hospital, and norepinephrine – NEO-SYNEPHRINE was deleted from the list.

Pediatric Drug Infusion Standard Concentrations Update – Changes were approved for the following standard drug infusion concentrations for pediatrics:  dobutamine, dopamine, epinephrine, vasopressin, aminophylline, ibuprofen lysine, levetiracetam, indomethacin.

Drug Shortages – Drugs that are currently on national shortage include:  acyclovir inj., aminophylline inj., bumetanide inj., calcium gluconate and chloride inj., chromium inj., dobutamine vials, dopamine vials, fosphenytoin, furosemide inj., magnesium sulfate inj., methyldopa inj., nalbuphine inj., and sodium bicarbonate inj.   Current drug shortages include many drugs not listed here.